A third COVID-19 vaccine

March 1, 2021
It’s March, again—but things are looking up because the FDA authorized a third COVID-19 vaccine for emergency use. We have details, plus USDA’s proposed framework for regulatory oversight of animal biotech, and our Women’s History Month kickoff. (930 words, 4 minutes,…
BIO

It’s March, again—but things are looking up because the FDA authorized a third COVID-19 vaccine for emergency use. We have details, plus USDA’s proposed framework for regulatory oversight of animal biotech, and our Women’s History Month kickoff. (930 words, 4 minutes, 39 seconds)

 

A third COVID-19 vaccine

 
 

On Saturday, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the COVID-19 vaccine developed by BIO member Janssen Pharmaceutical Companies of Johnson & Johnson—another important tool to help us beat the pandemic. 

This vaccine works. The single-dose vaccine is 85% effective in preventing severe disease, and 100% effective in preventing COVID-19-related hospitalization and death, says the company. In addition, the vaccine demonstrated protection against multiple variants, including the South African variant.

How it works: “The vaccine uses Ad26 [adenovirus type 26] to deliver a piece of the DNA…that is used to make the distinctive ‘spike’ protein of the SARS-CoV-2 virus,” says the FDA. This technology has been used in an approved Ebola vaccine as well as investigational Zika, HIV, and respiratory syncytial virus (RSV) vaccines. 

And it can be stored in a standard refrigerator, making it “a simpler option, particularly for more rural areas or communities with fewer pharmacies or clinics,” explains BioPharma Dive

What’s next: Nearly 4 million doses were shipped last night. As we reported last week, the company plans to ship enough for more than 20 million Americans by the end of March, and 100 million doses during the first half of the year. 

Do you have questions about the COVID-19 vaccines? Visit www.COVIDVaccineFacts.org.

ICYMI: Yesterday was Rare Disease Day. Read our new blog post celebrating progress on rare disease treatments and cures—and learn why future R&D is so important.

 
 
 
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BIO’s take on a proposed regulatory framework for animal biotech

 
 

Genetic engineering of animals used in agriculture has the potential to address some of our biggest challenges—from improving animal health and resiliency, to stopping the next zoonotic disease pandemic. But the current approach to regulating these animals is confusing and deters innovation. A new proposed framework for oversight could incentivize the development and use of this technology. 

Currently, animals modified or developed through genetic engineering are regulated as “new animal drugs,” overseen by the U.S. Food and Drug Administration (FDA).

BIO has long expressed concern over this approach, which deters R&D and unnecessarily stigmatizes these animals and their progeny, significantly reducing the likelihood that such animals will be grown by producers or accepted by consumers. (More background here and here.) 

The success of animal biotech is critically dependent on efficient and effective regulatory systems that ensure animal health and welfare, food safety, and protection of the environment—without disincentivizing development and commercialization of innovation. 

The U.S. Department of Agriculture (USDA) proposed a new framework for oversight of these animals, under which genetically engineered animals intended for agricultural use would be administered jointly by USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety Inspection Service (FSIS). 

BIO just submitted comments on the proposed framework, which is based on authorities more appropriate for overseeing animal health and creates a much clearer path to commercialization as well as greater transparency for consumers and stakeholders. 

The bottom line: BIO remains committed to continuing to work collaboratively with USDA, FDA, and other agencies to urgently develop a regulatory system that continues to ensure the safety of animals, consumers, and the environment while fostering innovation and expedited commercialization of beneficial improvements to agricultural animals.

Read BIO’s full comments.

 

More Agriculture and Environment News:

The New York Times: Global action is ‘very far’ from what’s needed to avert climate chaos
“New climate targets submitted by countries to the United Nations would reduce emissions by less than 1 percent, according to the latest tally, made public Friday by the world body.”

 
 
 
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BIO Celebrates Women's History Month
Rosalind Franklin.jpg

On the first day of Women’s History Month, it’s only fitting that we celebrate Dr. Rosalind Franklin, who not only broke barriers of sexism, but also paved the way for biotechnology innovations such as synthetic biology, biobased manufacturing, and carbon capture and utilization.

While Dr. Franklin was never nominated for a Nobel Prize, her work was crucial to the discovery of DNA’s structure—which, along with subsequent related work, led to Francis Crick, James Watson, and Maurice Wilkins being awarded a Nobel Prize in 1962, a few years after her death from cancer at age 37. 

Just as Rosalind Franklin paved the way for women in the biotechnology field, BIO’s Rosalind Franklin Award (sponsored by the Rosalind Franklin Society) is presented annually to a pioneering woman in the industrial biotechnology and agriculture sectors who has made significant contributions to the advancement of the biobased economy and biotech innovation.

 
BIO Beltway Report
BIO Beltway Report
 
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President Biden’s Monday: Meeting virtually with President of Mexico Andrés Manuel López Obrador; they are expected to discuss an immigrant labor program and COVID-19 vaccines

What’s Happening on Capitol Hill: Early Saturday morning, the House passed President Biden’s COVID-19 relief package, and he urged the Senate to take “quick action,” reports POLITICO. Expect another busy week of nomination hearings and discussions on the COVID-19 response, the January 6th insurrection, budgets, and more.

How you can support BIO's advocacy on the Payroll R&D Credit: The Payroll R&D Credit, established five years ago this past December, for the first time allowed pre-revenue innovators to take a portion of their R&D credit against their payroll tax obligation. It served as a recognition from Congress that income tax credits provide no immediate benefit to pre-revenue biotechs.

To support BIO’s advocacy to make sure the credit works for small biotechs, we have partnered with EY on a study to analyze credit utilization among small companies.

Click here to take this important survey.
Your participation will be instrumental in supporting our advocacy moving forward. Any information provided will only be viewed by EY and only reported in aggregate.

Read more about BIO’s advocacy to strengthen the Payroll R&D Credit. 

Questions? Respond to this email and we'll get you an answer.

 
 
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